# C_2017078EN.01001302.xml

| 13.3.2017 | EN | Official Journal of the European Union | C 78/13 |
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13.3.2017

EN

Official Journal of the European Union

C 78/13

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Appeal brought on 23 December 2016 by Dr. August Wolff GmbH & Co. KG Arzneimittel and Remedia d.o.o. against the judgment of the General Court (Fifth Chamber) of 20 October 2016 in Case T-672/14 Dr. August Wolff GmbH & Co. KG Arzneimittel and Remedia d.o.o. v European Commission

Dr. August Wolff GmbH & Co. KG Arzneimittel and Remedia d.o.o.

European Commission

(Case C-680/16 P)

(2017/C 078/19)

Language of the case: German

Parties

Parties

Appellants: Dr. August Wolff GmbH & Co. KG Arzneimittel, Remedia d.o.o. (represented by: P. Klappich and C. Schmidt, Rechtsanwälte)

Appellants:

Other party to the proceedings: European Commission

Other party to the proceedings:

Form of order sought by the appellants:

Form of order sought by the appellants:

The appellants claim that the Court should:

| 1. | set aside the judgment of the General Court of 20 October 2016 in Case T-672/14 and annul Commission Implementing Decision C(2014) 6030 final of 19 August 2014 concerning, in the framework of Article 31 of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations for human medicinal products for topical use containing high concentrations of estradiol in so far as that decision requires Member States to comply with the obligations imposed in the implementing decision for the medicinal products listed, and those not listed, in Annex I containing 0,01 % estradiol by weight for topical use, with the exception of the restriction that the medicinal products mentioned in Annex I to the implementing decision containing 0,01 % estradiol by weight for topical use may be administered only intravaginally; |
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1.

set aside the judgment of the General Court of 20 October 2016 in Case T-672/14 and annul Commission Implementing Decision C(2014) 6030 final of 19 August 2014 concerning, in the framework of Article 31 of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations for human medicinal products for topical use containing high concentrations of estradiol in so far as that decision requires Member States to comply with the obligations imposed in the implementing decision for the medicinal products listed, and those not listed, in Annex I containing 0,01 % estradiol by weight for topical use, with the exception of the restriction that the medicinal products mentioned in Annex I to the implementing decision containing 0,01 % estradiol by weight for topical use may be administered only intravaginally;

| 2. | in the alternative,
  set aside the judgment of the General Court in Case T-672/14 and refer the case back to that Court; |
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2.

in the alternative,

set aside the judgment of the General Court in Case T-672/14 and refer the case back to that Court;

| 3. | order the respondent to pay the costs of the proceedings. |
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3.

order the respondent to pay the costs of the proceedings.

Grounds of appeal and main arguments

Grounds of appeal and main arguments

The appellants rely on three grounds of appeal.

| 1. | First ground of appeal: infringement of Articles 31 and 32 of Directive 2001/83/EC

  It is submitted in this connection that the disputed implementing decision is based on a procedure which was initiated and conducted in a procedurally unlawful manner. The appellants first of all contend that, contrary to the first sentence of Article 31(1) of Directive 2001/83/EC, (1) the procedure was initiated not before, but only after the application for renewed authorisation of the medicinal product had been rejected. In the absence of up-to-date reports on safety concerns, there was also no particular EU interest at issue. Moreover, the appointment of a member of the Committee for Medicinal Products for Human Use (‘the CHMP’) as chief reporter from the Member State in which national proceedings had been initiated constitutes an infringement of the right under Article 41(1) of the Charter of Fundamental Rights of the European Union to have one’s affairs handled fairly and impartially. There is, in any event, objective and subjective partiality if, at the time when proceedings are initiated, proceedings are still pending between the Member State which provides the chief reporter and the holder of the marketing authorisation concerning the refusal to renew the authorisation for a medicinal product. Lastly, the appellants invoke an infringement of the right to a fair hearing, since in the proceedings before the CHMP the first appellant was not given an opportunity to comment on the intended content of the modification to the marketing authorisation. |
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1.

First ground of appeal: infringement of Articles 31 and 32 of Directive 2001/83/EC

First ground of appeal: infringement of Articles 31 and 32 of Directive 2001/83/EC

It is submitted in this connection that the disputed implementing decision is based on a procedure which was initiated and conducted in a procedurally unlawful manner. The appellants first of all contend that, contrary to the first sentence of Article 31(1) of Directive 2001/83/EC, (1) the procedure was initiated not before, but only after the application for renewed authorisation of the medicinal product had been rejected. In the absence of up-to-date reports on safety concerns, there was also no particular EU interest at issue. Moreover, the appointment of a member of the Committee for Medicinal Products for Human Use (‘the CHMP’) as chief reporter from the Member State in which national proceedings had been initiated constitutes an infringement of the right under Article 41(1) of the Charter of Fundamental Rights of the European Union to have one’s affairs handled fairly and impartially. There is, in any event, objective and subjective partiality if, at the time when proceedings are initiated, proceedings are still pending between the Member State which provides the chief reporter and the holder of the marketing authorisation concerning the refusal to renew the authorisation for a medicinal product. Lastly, the appellants invoke an infringement of the right to a fair hearing, since in the proceedings before the CHMP the first appellant was not given an opportunity to comment on the intended content of the modification to the marketing authorisation.

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| 2. | Second ground of appeal: infringement of the first sentence of Article 116 and of the first sentence of Article 126 of Directive 2001/83/EC

  The appellants here invoke, first of all, an infringement of the principles of a balanced burden of demonstration and proof since the CHMP based an altered benefit/risk assessment solely on the absence of studies relating to a merely hypothetical risk. The risk assessment undertaken by the CHMP was also flawed, since it failed to have sufficient regard to pharmacovigilance information. In that connection, the fact was overlooked that, during a market presence spanning more than 45 years, there had been no reports of serious risks resulting from use of the medicinal product that might have been capable of supporting the hypothetical risks relied on by the CHMP. The appellants claim further that the CHMP report does not contain any cogent or scientifically-sound justification for those hypothetical risks. |
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2.

Second ground of appeal: infringement of the first sentence of Article 116 and of the first sentence of Article 126 of Directive 2001/83/EC

Second ground of appeal: infringement of the first sentence of Article 116 and of the first sentence of Article 126 of Directive 2001/83/EC

The appellants here invoke, first of all, an infringement of the principles of a balanced burden of demonstration and proof since the CHMP based an altered benefit/risk assessment solely on the absence of studies relating to a merely hypothetical risk. The risk assessment undertaken by the CHMP was also flawed, since it failed to have sufficient regard to pharmacovigilance information. In that connection, the fact was overlooked that, during a market presence spanning more than 45 years, there had been no reports of serious risks resulting from use of the medicinal product that might have been capable of supporting the hypothetical risks relied on by the CHMP. The appellants claim further that the CHMP report does not contain any cogent or scientifically-sound justification for those hypothetical risks.

| 3. | Third ground of appeal: infringement of the principles of proportionality and equal treatment

  The appellants first rely on an infringement of the principle of proportionality inasmuch as, at least at the level of legal effect, account should have been taken of the fact that the risks were merely hypothetical and that it is extremely improbable that they would arise. It would therefore have been proportionate merely to update the warnings or to order a safety study to be carried out. Moreover, ruling out repeated use infringes the principle of equal treatment, since only an updating of the warnings was undertaken in relation to comparable medicinal products. The ruling out of repeated use was also ordered only in relation to medicinal products for which a risk of life-threatening health risks had been established. |
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3.

Third ground of appeal: infringement of the principles of proportionality and equal treatment

Third ground of appeal: infringement of the principles of proportionality and equal treatment

The appellants first rely on an infringement of the principle of proportionality inasmuch as, at least at the level of legal effect, account should have been taken of the fact that the risks were merely hypothetical and that it is extremely improbable that they would arise. It would therefore have been proportionate merely to update the warnings or to order a safety study to be carried out. Moreover, ruling out repeated use infringes the principle of equal treatment, since only an updating of the warnings was undertaken in relation to comparable medicinal products. The ruling out of repeated use was also ordered only in relation to medicinal products for which a risk of life-threatening health risks had been established.

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(1)  Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67).

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